Sr. Manager - Quality Assuarance

JOB Description

Department: Quality Assurance

Position: Sr. Manager / Head

Job Role:

• Preparation review of departmental Standard Operating procedure, Work Instructions and forms.
• Provide training to personnel on SOPs, work Institution, forms GMP and GDP compliance.
• Perform review and organize the qualification activities for the contract manufacturing organization, contract Testing Laboratory as per regulatory requirements to ensure GMP and GDP compliance.
• Monitoring and reporting on the effectiveness of the Quality management system within the organizations and at outsourced service providers.
• Initiation and Review of change control, Deviation and complaints as per requirement.
• Responsible for closing the QMS actions.
• Circulating and monitoring the QMS Dashboard activities.
• Review quality technical agreements with outsourced service providers.
• Assist the Qualified Auditors in performing audits at service providers facility.
• Monitor performance and help identity improvement and effectiveness of the Quality activities.
• Perform, review and organize supplier qualification activities for the Active Pharmaceutical Ingredients, excipients and packaging materials as per regulatory requirements to ensure GMP and GDP compliance.
• Creating, performing the software validation activities and related documentation.
• To carry out the assignments assigned by the Director and management.
• Manage and maintain an effective Quality Assurance program for the organisation in alignment with Global Operating Procedures.
• Ensure Vendor qualifications done at CMO/In-house.
• Discussion with CMO regarding compliance issues.
• Review operating procedures to ensure compliance with all related procedures, instructions and the Quality Manual.
• Provide guidance to the team in the development, implementation, monitoring and review of QA procedures.
• Establish procedures and methods to comply with applicable EU GMP & USFDA, ISO requirements and customer expectations.
• Ensures timely resolution to customer inquiries.
• Review customer requirements and make sure the system is in place to meet them.
• Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports with CMO.
• Drive continuous quality improvement projects at plant based on site data and customer expectations.
• Drive compliance to global harmonization initiatives.
• Assure proper use of change management associated with validated processes.
• Co-ordination with CMO & discuss the quality related issues in PV & routine commercial batches manufacturing.
• Review's data, analyses result and recommends changes based upon findings and performs follow up to verify effectiveness in PV & routine commercial batches manufacturing.
• Drive continuous quality improvement projects and global harmonization initiatives.
• Maintain clear communication paths with stakeholders.
• Identifies and determines quality improvement.
• Maintain clear communication paths with stakeholders.
• Performs other duties as assigned based on business needs.
• Co-ordinate Internal Stakeholders to move the processes in smooth manner.

Basic Qualifications:

• Education: M. Pharma/ M.Sc
• Experience: 8-15 years of experience in Quality Assurance / Quality System

Preferred Knowledge, Skills and Abilities:

• Superior organizational and leadership skills with ability to help team grow and thrive
• Experience with Customer interface and meeting customer expectations.
• Demonstrate team building and problem-solving skills
• Ability to effectively prioritize and escalate issues
• Working familiarity with Project Management
• Able to comply with the company's quality policy at all times

Company Website- https://www.novumgen.com/